Sr. Design Assurance Engineer - Medical Device

Job description

Description Job Summary: The Senior Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization working with cross-functional development teams to establish and maintain the design control deliverables, risk management activities, and DHF compliance to ensure delivery of the highest quality product to the customer. Essential Functions: - Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects and leading on-time completion of protocols, reports and assigned project deliverables - Accountable for Design Verification and Validation planning and /or, including active cross-functional root-cause analysis investigation & resolution activities - Lead Risk Management activities from product Concept through Commercialization - Support design test and inspection method development, and lead method validation activities - Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps - Support and ensure internal & external audit responses and on...